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Effects of an Exercise Snacking Intervention on Cognitive Function in Patients With Mild Cognitive Impairment: A Nationwide Multicenter Randomized Controlled Trial (ES-MCI)

14 settembre 2026 aggiornato da: Peking University
This multicenter randomized controlled trial aims to evaluate the effects of a Baduanjin-based exercise snacking intervention on cognitive function in older adults with mild cognitive impairment (MCI). A total of 240 participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group. The control group will receive routine health education, while the intervention group will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education. The exercise program consists of short bouts of Baduanjin practice distributed throughout the day to facilitate integration into daily life. Assessments will be conducted at baseline and at weeks 12, 24, and 48. The primary outcome is global cognitive function. Secondary outcomes include specific cognitive domains, physical function, emotional status, sleep, and other health-related measures. Exercise adherence, physical activity, and safety will also be evaluated.

Panoramica dello studio

Stato

Non ancora reclutamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Aged 51 to 80 years, inclusive.
  2. Meet the NIA-AA core clinical criteria for probable amnestic mild cognitive impairment (aMCI), including all of the following:

    1. A self-reported and/or informant-reported history of progressive memory decline lasting for more than 6 months, confirmed by a study neurologist;
    2. Objective impairment in one or two cognitive domains on standardized neuropsychological testing, with memory impairment required;
    3. Montreal Cognitive Assessment (MoCA) score of 18-26;
    4. Cognitive impairment does not result in significant functional dependence, with instrumental activities of daily living (IADL) remaining normal or only mildly impaired;
    5. Does not meet diagnostic criteria for any type of dementia.
  3. Able to independently use a smartphone and complete online check-ins, questionnaires, and other digital assessment tasks.
  4. Able to walk independently without assistance.
  5. No absolute contraindications to exercise, as determined by the Physical Activity Readiness Questionnaire or by a study physician when exercise-related risks are considered manageable.
  6. Willing and able to provide written informed consent.
  7. A primary caregiver, if applicable, is informed of and supportive of study participation.
  8. Willing and able to comply with the 24-month follow-up schedule and complete all study assessments and intervention tasks.
  9. Participants taking cognition-enhancing or other cognition-active medications may be included, provided that the medication dose has remained stable for at least 1 month before screening.

Exclusion Criteria:

  1. Cognitive impairment attributable to other causes, including:

    1. Meeting clinical diagnostic criteria for Alzheimer's disease or another type of dementia;
    2. Cognitive impairment primarily attributable to another clearly identified condition, including neurodegenerative diseases (e.g., Parkinson's disease, Huntington's disease, progressive supranuclear palsy, or multiple sclerosis), severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, or major depressive episode with psychotic features), or systemic diseases (e.g., uncontrolled thyroid dysfunction or vitamin B12 deficiency).
  2. Severe or unstable medical conditions, including any of the following:

    1. Acute cardiovascular or cerebrovascular event within the previous 6 months, including myocardial infarction, unstable angina, stroke, or transient ischemic attack;
    2. New York Heart Association (NYHA) class III or IV heart failure;
    3. Poorly controlled hypertension, defined as resting blood pressure ≥180/110 mmHg;
    4. Poorly controlled diabetes mellitus, defined as HbA1c >9.0%;
    5. Severe musculoskeletal disease resulting in inability to walk continuously for more than 100 meters;
    6. Severe respiratory disease;
    7. Malignancy with an estimated life expectancy of less than 2 years.
  3. Severe visual or hearing impairment that prevents the participant from adequately seeing assessment materials or hearing instructions despite the use of conventional corrective devices, such as glasses or hearing aids.
  4. High risk of falls, defined by any of the following:

    1. Two or more unprovoked falls during the previous year;
    2. A score of 0 on the balance component of the Short Physical Performance Battery (SPPB), indicating inability to stand with the feet together;
    3. Requirement for routine use of a walking aid or wheelchair.
  5. Current participation in another clinical trial that may affect cognitive function or physical activity.
  6. Planning to relocate outside the study area for more than 3 months during the next 24 months.
  7. Any other condition that, in the investigator's judgment, may compromise participant safety, data integrity, or adherence to the study protocol.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Baduanjin Exercise Snacking Group
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education. The intervention consists of brief, repeated bouts of Baduanjin exercise performed multiple times throughout the day. Standardized instructional videos and digital support will be provided to facilitate intervention delivery and adherence.
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education. The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment. Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence. Exercise intensity and safety will be monitored throughout the intervention period.
Comparatore attivo: Control Group
Participants will receive routine health education during the 24-week intervention period and will not receive the prescribed Baduanjin-based exercise snacking intervention.
Participants will receive a 24-week Baduanjin-based exercise snacking intervention in addition to routine health education. The intervention consists of brief bouts of Baduanjin exercise distributed throughout the day and is adapted to the cognitive and physical characteristics of older adults with mild cognitive impairment. Standardized instructional videos and digital support will be used to guide exercise performance and record intervention adherence. Exercise intensity and safety will be monitored throughout the intervention period.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 24
Lasso di tempo: Baseline and Week 24
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating better cognitive function. The primary outcome is the change in MoCA score from baseline to Week 24.
Baseline and Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Montreal Cognitive Assessment (MoCA) Score From Baseline to Week 12
Lasso di tempo: Baseline and Week 12
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening instrument covering multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating better cognitive function. The outcome is the change in MoCA score from baseline to Week 12.
Baseline and Week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Xiaoli Wang, PhD, Peking University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 settembre 2026

Completamento primario (Stimato)

15 ottobre 2026

Completamento dello studio (Stimato)

15 dicembre 2027

Date di iscrizione allo studio

Primo inviato

14 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 settembre 2026

Primo Inserito (Effettivo)

16 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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